We use cookies to offer you a better browsing experience, analyze site traffic, personalize content. Read about how we use Cookies, along with our Privacy Policy and Terms of Use. If you continue to use this site, you consent to our use of cookies.

curium jobs

Posted on 29th June 2020

Senior Regulatory Affairs Specialist

United States
Regulatory Affairs
Permanent
1492

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Regulatory Affairs Specialist responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to:

  • Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
  • Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
  • Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of post-approval changes
  • Author/compile/submit post-approval change supplements
  • Author/review updates to marketed product labeling
  • Maintain regulatory knowledge of current guidelines and regulations
  • Maintain current regulatory databases and produce various reports as needed
  • Utilize and support electronic document management system
  • Provides mentorship for entry-level and intermediate-level regulatory associates

Essential Functions

  • Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings
  • Understand, identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements
  • Manage multiple priorities
  • Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
  • Process, interpret and provide recommendations for complex, unusual issues.
  • Critically review documentation for regulatory submissions and provide input for necessary revisions.
  • Prepare Global PBRERs as required by relevant Health Authorities
  • Requirements:
  • Bachelor Degree in scientific discipline required or equivalent work experience.
  • Minimum 5 years of Regulatory Affairs experience or related field in a pharmaceutical environment. RAC certification preferred.
  • Strong knowledge of FDA/GMP requirements
  • Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
  • Excellent written and oral communication skills.
  • Use of electronic systems for preparation of eCTD submissions to FDA.
  • Use of TrackWise or similar system to manage change controls.
  • Strong background using Microsoft Office tools and Adobe Acrobat.
  • Travel Time Required – up to 10% (May vary depending on region/site)

Requirements

  • Bachelor Degree in scientific discipline required or equivalent work experience.
  • Minimum 5 years of Regulatory Affairs experience or related field in a pharmaceutical environment. RAC certification preferred.
  • Strong knowledge of FDA/GMP requirements
  • Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
  • Excellent written and oral communication skills.
  • Use of electronic systems for preparation of eCTD submissions to FDA.
  • Use of TrackWise or similar system to manage change controls.
  • Strong background using Microsoft Office tools and Adobe Acrobat.
  • Travel Time Required – up to 10% (May vary depending on region/site)

Working Conditions:

  • Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Standard office environment, coupled with time in radiopharmaceutical manufacturing and laboratory environments.
  • Must be willing to wear a variety of personal protective equipment.
  • Willingness to work in a team based environment.
  • Close attention to detail required.
  • May be required to sit or stand for long periods of time while performing duties.
  • Must be able to work outside of regular work hours.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • Must possess good hand-eye coordination.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Related positions

Posted on 25th June 2020

Associate Director of Regulatory Affairs

United States
Regulatory Affairs
Permanent
1496